Several devices have been developed in the past for the intravenous administration of medicaments. Some such devices are shown in U.S. Pat. Nos. 4,467,588 to Carveth; 4,871,354 to Conn et al.; 4,583,971 to Bocquet et al.; and 4,784,658 to Grabenkort. One such container system known in the art is currently sold by Abbott Laboratories of North Chicago, Ill. under the trademark ADD-VANTAGE.RTM.. This system is discussed in the aforementioned U.S. Pat. No. 4,784,658 to Grabenkort (hereinafter the "Garbenkort Patent"), as well as U.S. Pat. Nos. 4,614,267 to Larkin and 4,614,515 to Tripp et. al. which patents are hereby incorporated by reference into the present application.
As shown in the Grabenkort Patent, two container systems have become widely accepted for administering medicaments stored in a liquid, powdered or crystalline form. Since it is imperative that the medicaments not be contaminated prior to usage, sealed glass vials are used to store the medicaments until joined with a diluent container.
In Grabenkort, the diluent is stored in a sealed flexible bag made of plastic or other pliable material. The diluent container has two separate outlets provided at opposing ends of the diluent container. The first outlet is specifically designed to receive the first or additive container (i.e., glass vial) in which the medicament is stored; the second outlet provides a channel for dispensing the mixture of diluent and medicament (I.V. fluid).
Two container systems are desirable for the intravenous (I.V.) administration of medicaments, particularly those medicaments which have a short shelf life when mixed with diluent. In use, the additive or medicament container is joined with the diluent container in preparation for depositing the medicament in the diluent.
Several methods have been used to effectuate this joining step without contaminating the contents of either container. In the Grabenkort Patent, once the medicament enters the second container, the diluent and medicament are mixed by squeezing or shaking the second container for a prescribed period of time or until the medicament is dissolved and evenly mixed with the diluent. After mixing, the two containers are suspended on a rack so as to urge the I.V. fluid toward the second channel. The second channel may then be connected to a system for delivering the mixture to an I.V. system.
Although conventional two container systems have been effective in preventing contamination of their contents, and allowing use of medicaments having a short shelf life when mixed with diluent, their design can not ensure that mixing of the I.V. solution is effected prior to dispensing. With such prior art systems it is possible to dispense diluent intravenously prior to admixture. Prior to mixture it is possible to dispense the diluent prior to any mixing of the medicament. In such a circumstance, when a substantial portion of the diluent is dispensed prior to admixture of the medicament with the diluent, once mixing is performed the concentration of medicament in the dispensed mixture may dramatically increase. For this reason, the above-mentioned prior art system is suitable only for the mixing and dispensing of relatively non-toxic medicaments where the medicament admixture is not critical. In fact the above-discussed prior art system is not considered satisfactory for the mixing and intravenous dispensing of relatively toxic medicaments such as chemotherapeutic agents, radiopharmaceuticals and antimicrobials. This is despite the fact that other attributes of the above-mentioned system, such as the complete isolation of the health care technician from the medicament, are ideal for use such toxic medicaments.